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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. BIPOLAR LEAD NONE

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CYBERONICS, INC. BIPOLAR LEAD NONE Back to Search Results
Model Number 30X-UNK
Event Type  Injury  
Event Description

A vns treating physician reported that he had a pt who had undergone a right sided vns implantation after left sided lead break. Lead break reported in mdr report number: 1644487-2010-02958. It was reported that the pt was asymptomatic but experienced regular bradycardiac episodes during vns stimulation, lasting 30 secs. The event was observed repeatedly with drops in heart rate from 70bpm to 30bpm with stimulation, while pt was asleep and monitored. Good faith attempts are underway for further details about the reported event.

 
Manufacturer Narrative

Labeling recommends implantation of the lead on the left vagus nerve.

 
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Brand NameBIPOLAR LEAD
Type of DeviceNONE
Manufacturer (Section D)
CYBERONICS, INC.
houston TX
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste 600
houston , TX 77058
2812287200
MDR Report Key1953679
Report Number1644487-2011-02960
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation UNKNOWN
Type of Report Initial
Report Date 12/05/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/04/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator OTHER
Device MODEL Number30X-UNK
Was Device Available For Evaluation? No
Date Manufacturer Received12/05/2010
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 01/04/2011 Patient Sequence Number: 1
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